MalfunctionGAS
COR-KNOT
Received Feb 23, 2018 · Event occurred Feb 13, 2018
Report 7291636 · MDR key 7291636
Device
Generic name
Suture, Nonabsorbable, Synthetic, Polyester
Manufacturer
Lsi Solutions Inc.Model number
031350Lot number
692165
Product problems
- Positioning Failure
- Misfire
Patient
72 YR
- No Information
- No Information
Narrative
Description of Event or Problem
DURING AORTIC VALVE REPLACEMENT, THE COR-KNOT MISFIRED AND THE METAL DIVET SECURING THE VALVE IN PLACE DID NOT DEPLOY. THE SURGEON HAD TO PLACE ANOTHER VALVE SUTURE IN AND MANUALLY TIE IT IN. THIS EXTENDED THE SURGICAL CASE TIME.